In this article (8 sections)
- What is the difference between Section A and Section B of Annex I?
- Where will the AI requirements for machinery makers come from?
- What does the Machinery Regulation itself already do about AI?
- Which AI is not a safety component of machinery?
- After the move to Section B, which AI Act provisions still matter?
- FAQ
- Next in the series
- Legal sources and references
For Taiwanese makers of machine tools, automation equipment, robots and AGVs, the most important change in the Digital Omnibus is not in the timeline but in Annex I: the Machinery Regulation, Regulation (EU) 2023/1230, moves from Section A to Section B of AI Act Annex I. This means high-risk AI built into machinery no longer falls directly under the full set of AI Act Chapter III requirements; instead, the Machinery Regulation takes them over. This article explains what the change means, the timeline, and what it does not change.
Key takeaways
- The Omnibus deletes point 1 of Annex I Section A (the former Machinery Directive) and lists the Machinery Regulation (EU) 2023/1230 as point 21 of Section B.
- Under Article 2(2), only Article 6(1), Article 60a and Articles 102 to 112 of the AI Act apply to high-risk AI in Section B products.
- The substantive requirements will be taken over by a Commission delegated act amending Annex III of the Machinery Regulation (essential health and safety requirements); the Omnibus recitals state that it is intended to apply by 2 August 2028.
- The Machinery Regulation itself applies from 20 January 2027, and it already has its own requirements for safety components and machinery with self-evolving behaviour.
What is the difference between Section A and Section B of Annex I?
The high-risk route in Article 6(1) of the AI Act is based on the EU product legislation listed in Annex I. Annex I has two sections:
| Section A (New Legislative Framework legislation) | Section B (other product legislation) | |
|---|---|---|
| Typical products | Toys, lifts, radio equipment, pressure equipment, personal protective equipment, medical devices, in vitro diagnostic medical devices | Civil aviation, motor vehicles, agricultural and forestry vehicles, marine equipment, rail, drones, and after the Omnibus, machinery |
| How the AI Act applies | AI Act Chapter III applies directly, with conformity assessment carried out together with the product legislation | Only Article 6(1), Article 60a and Articles 102 to 112 apply; the requirements are written into each product law |
| High-risk application date | 2 August 2028 (Article 113, third paragraph, point (c)(ii)) | Depends on the amendments and delegated acts under each product law |
Put simply, Section A means “the AI Act regulates it directly”, and Section B means “the product legislation regulates it”. Moving machinery to Section B means moving from the first to the second.
Where will the AI requirements for machinery makers come from?
According to Recital 42 of the Omnibus, the Commission is to adopt a delegated act amending Annex III of the Machinery Regulation (essential health and safety requirements), bringing into the Machinery Regulation the relevant requirements of AI Act Chapter III, Section 2, together with the relevant content of Article 17 (quality management system), Article 19 (automatically generated logs), Article 72 (post-market monitoring) and Article 73 (reporting of serious incidents), with the intention that it applies by 2 August 2028.
Until harmonised standards for AI in machinery are published, manufacturers can rely on harmonised standards or common specifications under the AI Act to obtain a presumption of conformity.
So for machinery makers, the amendment means:
- A single assessment channel: the AI requirements will be handled within the Machinery Regulation conformity assessment, so you do not face two separate procedures.
- The content has not disappeared: risk management, data governance, technical documentation, logging, human oversight, accuracy and cybersecurity will all come back in the form of Machinery Regulation requirements.
- The timeline depends on the delegated act: the actual application date depends on when the delegated act is adopted and enters into force.
Does your equipment have any of these features?
- Machine learning for safety-related detection, such as stopping when a person approaches, anti-pinch protection or collision avoidance
- Autonomous movement or path planning (AGVs, AMRs, collaborative robots)
- Continuous learning during operation that adjusts the control logic
The Machinery Regulation applies from 20 January 2027; the delegated act on AI requirements is intended to apply by 2 August 2028.
Check the Machinery Regulation and AI Act timelines in the Regulatory Radar →
What does the Machinery Regulation itself already do about AI?
The Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC from 20 January 2027. AI was considered when it was drafted:
- Safety components with fully or partially self-evolving behaviour using machine learning approaches that ensure safety functions, and machinery with such systems embedded, are listed among the categories that require third-party conformity assessment;
- The essential health and safety requirements cover the safety of control systems with self-evolving behaviour and the risks of human and machine collaboration.
In other words, machinery makers will face the Machinery Regulation’s own AI-related requirements in 2027, and the delegated act will add the AI Act content before 2028. The two need to be planned together; it is not a matter of choosing one or the other.
Which AI is not a safety component of machinery?
The Omnibus also added Article 6(1a) to (1c) to the AI Act, narrowing the meaning of “safety component”:
- AI used only for non-safety aspects such as user assistance, performance optimisation, service efficiency, automation, convenience or quality control is not a safety component (paragraph 1a);
- But AI whose failure or malfunction would endanger health and safety still counts (paragraph 1b).
For example, AI that predicts tool wear, optimises machining parameters or detects visual defects is usually not a safety component if its failure would not endanger people. AI that determines whether a person has entered a danger zone and triggers a stop is one. Where this line falls is explained in detail in Part 5.
After the move to Section B, which AI Act provisions still matter?
Moving machinery to Section B removes the “direct application” of the Chapter III high-risk requirements, not the whole AI Act:
- Article 50 transparency: if the equipment’s operating interface has a chatbot or generative features, Article 50 still applies (see Part 2).
- Article 5 prohibited practices: for example, using AI to infer the emotions of operators in the workplace (except for medical or safety reasons).
- Annex III uses: if data collected by the equipment is used to evaluate operator performance or allocate work, that is a separate high-risk route (see Part 7).
- Article 4 AI literacy.
Plan 2027 and 2028 together
The same machine has to meet the Machinery Regulation in January 2027 and the AI requirements of the delegated act by 2028, so it is best to plan technical documentation, risk assessment and test data in one go. Which models to tackle first and which features need redesign depends on your product lines and sales structure.
FAQ
Now that machinery has moved to Section B, can machinery AI ignore the AI Act?
No. AI Act Chapter III no longer applies directly, but the relevant requirements will return through the delegated act under the Machinery Regulation; Article 50 transparency, the Article 5 prohibited practices and the Annex III uses still apply.
When does the Machinery Regulation apply?
Regulation (EU) 2023/1230 applies in principle from 20 January 2027, replacing the Machinery Directive 2006/42/EC.
When will the delegated act on AI requirements come out?
According to the Omnibus recitals, the delegated act amending Annex III of the Machinery Regulation is intended to apply by 2 August 2028. At the time of this update it has not been published in the Official Journal, so keep tracking it.
Is predictive maintenance AI high-risk?
If it is used only for performance optimisation or service efficiency, and its failure would not endanger health and safety, it is not a safety component under Article 6(1a), and it will usually not become high-risk through the Annex I route.
Next in the series
Previous: Part 3: Are you a provider or a deployer? Determining your AI Act role
Need help?
ZC Zeelandia Consulting has an office in Amsterdam and can help equipment makers confirm the applicability of the AI Act and the Machinery Regulation, and plan the order of preparation for 2027 and 2028.
- Book a 30-minute online consultation: calendly.com/zc-meeting/30min
- EU Regulatory Radar: AI Act page
- Follow ZC on LINE: lin.ee/QKV5RTE
Legal sources and references
- Regulation (EU) 2024/1689 (Artificial Intelligence Act), Article 2(2), Article 6 and Annex I: EUR-Lex
- Regulation (EU) 2026/1744 (Digital Omnibus on AI), Recital 42: EUR-Lex
- Regulation (EU) 2023/1230 on machinery: EUR-Lex
- AI Act consolidated text (27 July 2026): EUR-Lex
This article provides general information, updated to November 2026, and does not constitute legal advice. Whether a specific product is affected depends on the actual facts and the latest Official Journal texts.
Next step: have you considered these three options?
Sources · Regulation (EU) 2024/1689 (Artificial Intelligence Act) · Regulation (EU) 2026/1744 (Digital Omnibus on AI) · Regulation (EU) 2023/1230 on machinery · AI Act consolidated text (27 July 2026). This article is general information and not legal advice for any specific case. Obligations are defined by the Official Journal of the EU.
AI ActMachinery Regulation2023/1230machine toolsrobotssafety componentAnnex I
